510(k) · Cleared
ClearedCoLumbo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smart Soft Healthcare AD · QIH Automated Radiological Image Processing Software
Cleared on Jun 23, 2022 as substantially equivalent to K193290 (Siemens Medical Solutions USA, Inc., 2020) after a 121-day review. Its family tree reaches back 17 generations to 1997. 5 of the 200 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it.
- Decided
- Jun 23, 2022
- Review
- 121 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K971684 (1997). 193 ancestors in all, the oldest K837107 (1983). 6 later devices descend from it, 4 citing it directly. 5 of the 200 devices in this family, counting this one, have a Class I recall.
- Root · 17 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 13 generations between
- 3 generations backK180336 syngo.MR ApplicationsSiemens Medical Solutions USA, Inc. · 2018
- 2 generations backK182904 syngo.MR ApplicationsSiemens Medical Solutions USA, Inc. · 2019
- 1 generation backK193290 AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc. · 2020
- This deviceK220497 CoLumboSmart Soft Healthcare AD · 2022
- Descendant · cites it directly · 2 of its ownK241211 CoLumboSmart Soft Healthcare · 2024
- Descendant · 2 generations on · 0 of its ownK254015 CoLumbo C-SpineSmart Soft Healthcare AD · 2026
- Descendant · 2 generations on · 0 of its ownK250367 CoLumboXSmart Soft Healthcare AD · 2025
- Descendant · cites it directly · 0 of its ownK242607 ScanDiags Ortho L-Spine MR-QScandiags AG · 2025
- Descendant · cites it directly · 0 of its ownK240793 MSKaiMskai · 2024
Show all 17 generations
- Root · 17 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 16 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 15 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 14 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 13 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 12 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 11 generations backK082427 Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008
- 10 generations backK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
- 9 generations backK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 8 generations backK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
- 7 generations backK130749 Syngo.MR General; Syngo.MR Cardiology; Syngo.MR VascularSiemens Medical Solutions USA, Inc. · 2013
- 6 generations backK133401 Syno MR Neurology, Syngo MR Oncology, Syngo. MR Brevis, Syngo MMR…Siemens Medical Solutions USA, Inc. · 2014
- 5 generations backK151353 syngo.MR Neurology, syngo.MR OncologySiemens Medical Solutions USA, Inc. · 2015
- 4 generations backK163294 syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc. · 2017
- 3 generations backK180336 syngo.MR ApplicationsSiemens Medical Solutions USA, Inc. · 2018
- 2 generations backK182904 syngo.MR ApplicationsSiemens Medical Solutions USA, Inc. · 2019
- 1 generation backK193290 AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc. · 2020
- This deviceK220497 CoLumboSmart Soft Healthcare AD · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K153343 MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma…5 generations back · 2016
- K121434 Software Syngo MR D13A for the Magnetom Systems…5 generations back · 2012
- K101347 Magnetom Aera; Magnetom Skyra5 generations back · 2010
- K151579 MAGNETOM Aera (24-channel), MAGNETOM Avanto fit…6 generations back · 2015
Most influential descendants
Showing 5 of 6 · See all- K241211CoLumboSmart Soft Healthcare · 2024 · cites it directly2descendants
- K254015CoLumbo C-SpineSmart Soft Healthcare AD · 2026 · 2 generations on0descendants
- K250367CoLumboXSmart Soft Healthcare AD · 2025 · 2 generations on0descendants
- K242607ScanDiags Ortho L-Spine MR-QScandiags AG · 2025 · cites it directly0descendants
- K240793MSKaiMskai · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −16 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −15 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −14 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −13 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −12 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −11 | K082427 | Syngo MR B17 | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −10 | K101347 | Magnetom Aera; Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2010 | Class I |
| −9 | K111242 | Magnetom Aera and Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2011 | 3 |
| −8 | K121434 | Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio | Siemens Medi Cal Solutions, Inc. | 2012 | Class I |
| −7 | K130749 | Syngo.MR General; Syngo.MR Cardiology; Syngo.MR Vascular | Siemens Medical Solutions USA, Inc. | 2013 | — |
| −6 | K133401 | Syno MR Neurology, Syngo MR Oncology, Syngo. MR Brevis, Syngo MMR General | Siemens Medical Solutions USA, Inc. | 2014 | — |
| −5 | K151353 | syngo.MR Neurology, syngo.MR Oncology | Siemens Medical Solutions USA, Inc. | 2015 | — |
| −4 | K163294 | syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology | Siemens Medical Solutions USA, Inc. | 2017 | — |
| −3 | K180336 | syngo.MR Applications | Siemens Medical Solutions USA, Inc. | 2018 | — |
| −2 | K182904 | syngo.MR Applications | Siemens Medical Solutions USA, Inc. | 2019 | — |
| −1 | K193290 | AI-Rad Companion Brain MR | Siemens Medical Solutions USA, Inc. | 2020 | — |
| 0 (this device) | K220497 | CoLumbo | Smart Soft Healthcare AD | 2022 | — |
| +1 | K241211 | CoLumbo | Smart Soft Healthcare | 2024 | — |
| +2 | K254015 | CoLumbo C-Spine | Smart Soft Healthcare AD | 2026 | — |
| +2 | K250367 | CoLumboX | Smart Soft Healthcare AD | 2025 | — |
| +1 | K242607 | ScanDiags Ortho L-Spine MR-Q | Scandiags AG | 2025 | — |
| +1 | K240793 | MSKai | Mskai | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 6 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 9 | 0 |
| 1997 | 8 | 0 |
| 1998 | 12 | 0 |
| 1999 | 6 | 0 |
| 2000 | 11 | 0 |
| 2001 | 18 | 0 |
| 2002 | 14 | 0 |
| 2003 | 8 | 0 |
| 2004 | 15 | 0 |
| 2005 | 10 | 0 |
| 2006 | 10 | 0 |
| 2007 | 8 | 0 |
| 2008 | 3 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 1 |
| 2016 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
5 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.6 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K193290 | AI-Rad Companion Brain MRSummary page 4…Magnetic resonance diagnostic device Classification Product Code: LLZ Subsequent Product Code: LNH Classification Panel: Radiology Device Class: Class II 510(k) Number: K193290 cleared July 5, 2019 Reference Device 1: Device Name: AI-Rad Companion (Cardiovascular) Manufacturer: Siemens Medical Solutions U… | 2020 |
| † | K183268 | AI-Rad Companion (Cardiovascular) | 2019 |
| † | K193267 | Al-Rad Companion (Musculoskeletal) | 2020 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc. · 2016 · 5 generations back · ◆ in the 2016 ancestors bar of FIG. 11 Class I recall
- K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · 5 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 5 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K151579MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medical Solutions USA, Inc. · 2015 · 6 generations back · ◆ in the 2015 ancestors bar of FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 6 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 45 of the 193 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K241211 (Smart Soft Healthcare, 2024) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K193290.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
CoLumbo is an image post-processing and measurement software tool that provides quantitative spine measurements from previously-acquired DICOM lumbar spine Magnetic Resonance (MR) images for users' review, analysis, and interpretation. It provides the following functionality to assist users in visualizing, measuring and documenting out-of-range measurements: - Feature segmentation; - Feature measurement; - Threshold-based labeling of out-of-range…
Read the full statement (193 words)
CoLumbo is an image post-processing and measurement software tool that provides quantitative spine measurements from previously-acquired DICOM lumbar spine Magnetic Resonance (MR) images for users' review, analysis, and interpretation. It provides the following functionality to assist users in visualizing, measuring and documenting out-of-range measurements:
- Feature segmentation;
- Feature measurement;
- Threshold-based labeling of out-of-range measurement; and
- Export of measurement results to a written report for user's review, revise and approval.
CoLumbo does not produce or recommend any type of medical diagnosis or treatment. Instead, it simply helps users to more easily identify and classify features in lumbar MR images and compile a report. The user is responsible for confirming/modifying settings, reviewing and verifying the software-generated measurements, inspecting out-of-range measurements, and approving draft report content using their medical judgment and discretion.
The device is intended to be used only by hospitals and other medical institutions.
Only DICOM images of MRI acquired from lumbar spine exams of patients aged 18 and above are considered to be valid input. CoLumbo does not support DICOM images of patients that are pregnant, undergo MRI scan with contrast media, or have post-operational complications, scoliosis, tumors, infections, fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220497 · printed Nov 4, 2026
Cite this page
510(k) Report. “K220497: CoLumbo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220497
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026